Page 1 INSTRUCTIONS FOR USE HEATERCOOLER UNIT HCU 40...
Page 2 All rights reserved. No part of this publication may be duplicated, adapted or translated without prior written permission, except under the terms of the copyright laws. © Copyright Maquet Cardiopulmonary GmbH Subject to technical changes Owing to our policy of continuous product development, the illustrations and technical data contained in this document may differ slightly from the current version of the device.
Page 3: Table Of Contents
Intended Environment ................12 2.1.6 Contraindications ..................12 General Safety Instructions................12 2.2.1 Precautionary Measures...............12 2.2.2 Position of Use and Operation and Positioning of the HCU 40 ....13 2.2.3 Handling the HCU 40................14 2.2.4 Water Circuits and Heat Exchangers ...........14 2.2.5 Monitoring and Sensors................16 2.2.6...
Page 4 3.11.4 Using a Selection List ................36 3.11.5 Using a Wizard ..................36 3.11.6 Locked Controls..................36 Operation ........................38 Positioning and Connecting the Device ............38 4.1.1 Setting up and Connecting the HCU 40 ..........38 4.1.2 Connecting a Control Unit ..............39 4.1.3 Connecting External Devices (Optional)..........39 4.1.4 Connecting External Temperature Sensors (Optional)......39...
Page 5 Key User Functions...................75 4.8.1 Calling Up the "Service" Screen ............76 Troubleshooting ......................78 Causes of Faults and Measures to Take ............78 Messages........................81 Alarms.......................81 6.1.1 Duration and Intervals for Acoustic Alarms ..........81 Alarm List ......................81 Physiological Alarms..................82 6.3.1 Medium Priority..................82 Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 6 Send Device to Authorized Service Point ..........131 Authorized Service....................131 Initial Installation......................132 Accessories.........................133 Technical Data ......................135 11.1 HCU 40 Device ....................135 11.2 Control Unit CU....................136 11.3 Permissible Heat Exchangers................136 11.3.1 Oxygenator and Cardioplegia Heat Exchangers ........136 11.3.2 Blanket Connection Kit (incl. Pressure Reducer) .........137 11.4 Components Supplied..................137...
Page 7 11.10.22 per cent Chloramine-T concentration for weekly routine disinfection of various tube lengths .................141 11.10.35 per cent Chloramine-T concentration for highly effective disinfection and biofilm removal of various tube lengths ......142 Applied Standards.......................143 12.1 Electromagnetic Compatibility (EMC) ...............143 Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 8: General
| 8 | 1 General | HCU 40 | 1 General 1.1 Information on these Instructions for Use These Instructions for Use will familiarize you with the features of the Maquet device. 1.1.1 Symbols References References to other pages in these Instructions for Use begin with the arrow sign "⇨".
Page 9: Environmental Protection
1.2 Environmental Protection 1.2.1 Packaging All packaging materials are made of environmentally safe materials. On request, Maquet will be happy to dispose of the packaging materials. 1.2.2 Batteries Batteries can be disposed of via the local recycling center. 1.2.3 Disposal...
Page 10 | 10 | 1 General | HCU 40 | Heatercooler unit Temperature measured at the external sensor Temperature measured at the water outlet Setpoint temperature Temperature measured in the tank tank Universal serial bus ΔT Setpoint gradient Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 11: Safety
The temperature transfer occurs via a heat exchanger in the patient perfusion circuit and/or cardioplegia water circuit and/or via a warming/ cooling blanket. 2.1.3 Intended User The HCU 40 may only be operated by trained specialist medical staff. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 12: Intended Patient
91). If a defective warming/cooling blanket is used with an electrosurgical unit which is either not grounded or incorrectly grounded, this may result in burns to the patient (⇨ "Connecting a Heat Exchanger", page 52). Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 13: Position Of Use And Operation And Positioning Of The Hcu 40
| HCU 40 | 2 Safety | 13 | 2.2.2 Position of Use and Operation and Positioning of the HCU 40 The HCU 40 must be positioned so that the user can see all of the displays at all times, can operate all of the controls and components and access interfaces, and so that the HCU 40 is not interfered with by other devices or vice versa.
Page 14: Handling The Hcu 40
Have the device checked/repaired by authorized service personnel. Use a replacement device in an emergency. 2.2.4 Water Circuits and Heat Exchangers WARNING! Switch the device off before intra-hospital transportation. Remove all connected cables. Observe the shipping information (⇨ "Send Device to Authorized Service Point", page 131). Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 15 HCU 40 and the heat exchanger. The water tank must only be filled with sterile filtered water and other substances which have been specified by Maquet. Check all water tubes and tube connections for leaks prior to the application.
Page 16: Monitoring And Sensors
While performing longer normothermal applications, avoid abrupt hypothermia, which could endanger the patient's health, by employing the following measures: Do not add any ice; Deactivate the ice formation or do not use any ice (⇨ "Changing the Setpoint Ice Block Size", page 61). Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 17: Electromagnetic Compatibility
Only use the specified accessories (⇨ "Accessories", page 133). The use of other devices, systems, or accessories may increase RF emissions or reduce the immunity to interference. 2.3 Symbols Symbols on the rating plates of the HCU and control unit (CU) Notice! Observe the warnings and safety precautions given in the accompanying docu mentation. Warning: Dangerous voltage Observe the instructions in the Instructions for Use! Protection type in accordance with IEC 60529: Protection against ingress of solid foreign objects larger than 12.5 mm and dripping water when tilted up to 15°. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 18 | 18 | 2 Safety | HCU 40 | Classification in accordance with IEC 606011: Type B applied part. Alternating current Date of manufacture: MonthYear in which the device was made. Manufacturer as defined by Council Directive 93/42/EEC concerning medical devices. Fragile Do not expose to direct sunlight Store in a dry place Temperature restriction Air humidity restriction Air pressure restriction Separate collection of electric and electronic devices in accordance with Directive 2012/96/EC: Do not dispose of the device with normal domestic waste. Keep separate from domestic waste and dispose of in an environmentally safe way in compliance with local regulations. The device meets the requirements of Council Directive 93/42/EEC concerning medical products. The device confirms to Canadian and American safety standards CSA C22.2 No. 601.1 and UL 606011. 710165 Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 19 | HCU 40 | 2 Safety | 19 | Follow the Instructions for Use! Symbols on HCU "Control unit (CU)" connection Patient water circuit 1 Patient water circuit 2 Cardioplegia water circuit Water outlet Water inlet (backflow) Port for external power supply Equipotential bonding Symbols on the housing of the control unit (CU) "T " connection for cardioplegia water circuit "HLM" connection (not used) "HCU" connection USB port "T " connection for patient water circuit Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 20: Rating Plates
AC power supply The values on the rating plate shown are examples and may differ from the rating plate on the device. Control unit (CU) The rating plate is on the rear of the control unit (CU). Order number Devicespecific serial number Devicespecific date of manufacture Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 21: System Description
| HCU 40 | 3 System Description | 21 | 3 System Description 3.1 How the HCU 40 Functions The heater-cooler unit HCU 40 can be used to cool or warm a patient during cardiovascular interventions and to regulate patient temperature. The system includes two separate water circuits, the temperature of which can be regulated independently of each other.
Page 22: System Overview
| 22 | 3 System Description | HCU 40 | 3.2 System Overview Control unit (⇨ "Control Unit CU", page 24) Tank cover Front view On/Off switch with LED ring Stopcocks and connections for cardioplegia water circuit Stopcocks and connections for patient water circuit Rating plate Equipotential bonding connection AC power cord Mains circuit breaker "Control unit (CU)" holder Standard slide rail at rear Rear view Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 23: Water Circuit Controls
3.4 Controls for Electrical Connections 3.4.1 Status of the On/Off switch The On/Off switch displays the status of the HCU 40 via the LED ring: Status of On/Off switch Explanation/cause LED ring is not lit. Device switched off. LED ring is steady green. Device running, no errors. LED ring flashes green. Selftest during startup (⇨ "Switching On the HCU 40, SelfTest", page 43) Diagnosis running (⇨ "Perform Diagnosis", page 129) Control unit not connected up (⇨ " Connecting a Control Unit", page 39) Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 24: Control Unit Cu
(pressing), you can confirm the selected function, selection, or setting. 3.5.2 Touchscreen The touchscreen can be used to navigate through menu items, change settings, and select functions. 3.6 Touchscreen, Display Areas Status bar (⇨ "Status Bar", page 25) Toolbar (⇨ "Toolbar", page 26) "Warming" and "Cooling" hotkeys (⇨ ""Warm ing" and "Cooling" Hotkeys", page 26) Parameter display (⇨ "Parameter Display", page 27) Pump control (⇨ "Pump Control", page 28) Main screen with external temperature sensors Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 25: Status Bar
If there are several alarm situations with the same priority simultaneously, the status bar displays the last alarm situation to occur. If there are several alarm situations with different priorities simultaneously, the status bar displays the alarm situation with the highest priority. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 26: Toolbar
Changing the Hotkey Settings", page 59). You can use two separate hotkeys for cooling and warming. You can set the values for the patient circuit and cardioplegia water circuit independently of each other for each hotkey. Symbol Hotkey [Warm patient water circuit] Hotkey [Warm cardioplegia water circuit] Hotkey [Cool patient water circuit] Hotkey [Cool cardioplegia water circuit] Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 27: Parameter Display
Even once the required temperature is reached at the water outlet (T ), the externally measured temperature (T ) may deviate because of heat/cold loss between the water outlet and the external temperature sensor. The loss depends on different factors such as tube lengths and the ambient temperature. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 28: Pump Control
3.7 Main Screen In this screen, the touchscreen displays the most important parameters. The screen is displayed automatically after the HCU 40 is switched on. The [Main screen] symbol can be used to switch to the main screen at any time. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 29: Functions
(⇨ "Setting the Warning Limits for the External Temperature", page 48) Start/stop circulation (⇨ "Starting/Stopping Circulation", page 46) Activate Gradient mode (⇨ "Gradient Mode", page 49) Use hotkeys (⇨ "Using Hotkeys", page 47) 3.8 Functions [Functions] symbol opens the "Functions" screen. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 30: De-Airing The Circuits
To this end, the touchscreen displays the symbols for de-airing in the "Functions" screen. Function Meaning Deairing can be started. To start the deairing, touch the symbol of the circuit that you want to deair. Deairing running. To stop the deairing, touch the symbol. Deairing completed, tem The circuit is deaired; the temperature of the water is be perature regulation running. ing regulated. Deairing and temperature The outlet temperatures have attained the setpoint tem regulation completed. peratures. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 31: Emptying Tubes
The status bar indicates when the compressor is running by displaying a symbol (⇨ "Status Bar", page 25). [Compressor control] button is visible in the "Functions" screen. You can also use this button to switch the compressor on and off manually. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 32: Settings
Compressor was stopped The stopping of the compressor may have the following automatically. causes: The time for the restart is too short. The setpoint ice block size has been reached or exceeded. There is no ice demand. Power consumption of the compressor and the electrical heater is controlled automatically. During warming, the compressor is switched off as a function of the current available in favor of the heater. 3.9 Settings [Settings] symbol opens the "Set- tings" screen. In this screen, you have the following options: Function Meaning Alarm list Alarm list (⇨ "Alarm List", page 81) Tank Displaying tank status (⇨ "Displaying the Tank Status ", page 66) Displaying ice block size (⇨ "Displaying the Ice Block Size", page 67) Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 33: System Settings
Patient water circuit hotkeys Changing the hotkey settings (⇨ "Changing the Hotkey Settings", page 59) Cardioplegia water circuit Changing the hotkey settings (⇨ "Changing the Hotkey hotkeys Settings", page 59) Water flow Changing the water flow (⇨ "Changing the Water Flow", page 62) System System settings (⇨ "System Settings", page 33) 3.9.1 System Settings The "Settings" screen can be used to open the "System settings" screen. Function Meaning Power supply Displaying the power supply status (⇨ "Displaying the Power Supply Status", page 70) Diagnosis Perform diagnosis (⇨ "Perform Diagnosis", page 129) System information Display system information (⇨ "Displaying System Infor mation", page 70) Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 34: Pausing The Current Alarm
There is no current alarm that could be paused. 3.11 Basic Handling Information for Software 3.11.1 Confirming or Rejecting Inputs/Changes If you enter or change data you must confirm or reject it. To this end, the touchscreen displays the following symbols: Symbol Description Confirm To confirm the inputs or changes, touch the symbol. The HCU 40 uses the new, changed settings. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 35: Switching Functions On And Off
Active fields with a numerical display are shown with blue background and white lettering. Selected symbols lead to selected screen. To increase the value, turn the rotary knob clockwise. To reduce the value, turn the rotary knob counterclockwise. Press the rotary knob to confirm the setting. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 36: Using A Selection List
Whether and after what period of time the lock is activated, can be defined in the settings (⇨ "Changing the Hotkey Settings", page 59). The padlock symbol in the status bar shows whether the HCU 40 is locked: Unlock Meaning HCU 40 locked To be able to use the HCU 40, the lock must be removed. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 37 Touch the symbols "key 1" and "key 2" one after the other. Select and confirm the symbols "key 1" and "key 2" one after the other with the rotary knob. ▶ The HCU 40 removes the lock. You can use the controls until they are locked again automatically. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 38: Operation
WARNING! Please note the requirements regarding position of use and operation and positioning (⇨ "Position of Use and Operation and Positioning of the HCU 40" , page 13). Please note the requirements regarding the power supply and supply line (⇨ "...
Page 39: Connecting A Control Unit
4.1.4 Connecting External Temperature Sensors (Optional) You can connect external temperature sensors to the HCU 40 in order to display the measured temperatures (⇨ "Parameter Display", page 27) and to use the gradient mode (⇨ "Gradient Mode", page 49). Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 40: Securing Set Of Slide Rails For Tubing Holder (Optional)
Release the three screws of the cover on the right and left side of the HCU 40 Attach the slide rails to the right and left side of the HCU 40. 4.1.6 Opening/Closing Stopcocks Turn the desired stopcock to the vertical position to open it. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 41: Filling/Topping Up Water
Level adjustment between the cardioplegia tank and the main tank can be delayed if filling is performed very quickly. Open the tank cover. Add water up to no higher than the level marking in the cardioplegia tank (1 cm above the evaporizer plates). Close the tank cover. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 42: Connecting/Removing Water Tubes
Connecting a Heat Exchanger", page 52). Establishing the water circuit with the cleaning connector (double Hansen coupling) (⇨ "Creating a Water Circuit", page 52). Removing the water tubes Empty the tube system (⇨ "Emptying Water Circuits", page 58). Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 43: Using The System
CAUTION! Close the stopcocks before removing the water tubes. Pull back the ring on the quick-release coupling. Remove the tube. 4.2 Using the System 4.2.1 Switching On the HCU 40, Self-Test Ensure that the mains circuit breaker is turned on and there is power to the unit.
Page 44 After the self-test, the touchscreen displays the main screen (⇨ "Main Screen", page 28): Main screen with external temperature sensors Main screen without external temperature sensors Display in case of error Should an error occur during the self-test, the touchscreen displays a self-test failure report. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 45: Setting And Changing Setpoint Temperatures
If you set a setpoint temperature of 1°C, the internal mixing valve opens completely to the tank. This provides the maximum available cooling capacity. Touch the symbol "T " for the circuit whose setpoint temperature you wish to change. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 46: Starting/Stopping Circulation
▶ The HCU 40 cools or warms the water in the circuits until the measured temperatures at the water outlets have attained the setpoint temperature, and maintains these temperatures. Touch [Patient water circuit pump] and/or [Cardioplegia water circuit pump]. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 47: Using Hotkeys
The setpoint gradient is only used if external temperature sensors are connected. Gradient mode is deactivated with the value [Off]. If you do not want to use the values, touch the [Reject] symbol instead. Cause Message Setpoint temperature Temperature setting may be harmful to health! > 39.4°C Setpoint temperature < 33.0°C Gradient > 8.0°C Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 48: Setting The Warning Limits For The External Temperature
To display or change the settings, touch the symbol of the corresponding temperature sensor. ▶ The touchscreen displays the following window: Example: warning limits for external temperature sensor patient circuit with deactivated lower warning limit. The same applies for the cardioplegia water circuit. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 49: Gradient Mode
This means that the HCU 40 automatically adjusts the water output temperature to the venous patient or cardioplegia temperature measured by the sensor until the setpoint temperature (T ) at the water outlet is attained. The Gradient mode thus protects the patient from too abrupt warming/cooling. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 50 For the cardioplegia water circuit connect the temperature sensor to the cardioplegia heat exchanger. Touch the symbol of the corresponding circuit. ▶ The Gradient mode is not automatically active; the fields display [Off]. To set the gradient, touch until the touchscreen displays the desired limit value. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 51 [Off]. To reactivate Gradient mode, touch until the touchscreen displays the desired limit value. To accept the changes, touch the [Confirm] symbol. If you wish to reject the changes, touch the [Reject] symbol instead. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 52: Water Circuits
Connect the water tubes (⇨ "Connecting/Removing Water Tubes", page 42). Connect the heat exchanger and/or the warming/cooling blanket (⇨ " Connecting a Heat Exchanger", page 52). Open the stopcocks. De-air the water circuits (⇨ "De-airing the Circuits", page 56). 4.3.2 Connecting a Heat Exchanger Oxygenator heat exchanger Warming/cooling blanket Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 53 The tubes of the perfusion system used should not be too long. Insert the external temperature sensors (optional) fully into the measurement device in the perfusion system and lock into place. Connect the water tube from the water outlet to the water inlet of the oxygenator heat exchanger. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 54 The couplings are coded with symbols for the patient water circuit and for the direction of flow. Open the stopcock of the patient water circuit P1. ▶ The handle is in the vertical position: The stopcock is open. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 55 This mat acts as the interface that either keeps the patient warm or cool. Its temperature is adjusted to a preset value by the heater-cooler unit. NOTE Observe the corresponding Instructions for Use when connecting and using the warming/cooling blanket. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 56: De-Airing The Circuits
It generally makes sense to de-air the circuits with connected heat exchangers. In exceptional situations, it is also possible to de-air without heat exchangers (⇨ " Key User Functions", page 75). Create the required water circuit (⇨ "Creating a Water Circuit", page 52). Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 57 Once the circuit has been de-aired, a green check mark appears next to [De-airing] symbol. ▶ The de-airing is followed by temperature regulation. The water is regulated to the preset temperature. NOTE: During de-airing, water is taken from the tank, and water flows into Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 58: Emptying Water Circuits
This function only empties the selected water circuit. If you want to empty the entire system, including the tank, ice block, etc., instead, use the [Empty system] function (Emptying the Tank). Touch the [Functions] symbol. Stop the circulation (⇨ "Starting/Stopping Circulation", page 46). Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 59: System Configuration
The HCU 40 cancels the emptying if a time limit of 2 minutes expires or the maximum water level of the tank is achieved. 4.4 System Configuration 4.4.1 Changing the Hotkey Settings You can set the gradients for the patient and cardioplegia water circuit independently of each other. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 60 The touchscreen displays a warning symbol if the setting may be harmful (see table below). To accept the changes, touch the [Confirm] symbol. If you wish to reject the changes, touch the [Reject] symbol. Cause Message Setpoint temperature > 39.4°C Temperature setting may be harmful to health! 15.5°C < setpoint temperature < 33.0°C Temperature setting may lead to ventricular fib rillation or cardiac arrest Setpoint temperature < 15.6°C Temperature setting may be harmful to health! Gradient > 8.0°C Temperature setting may be harmful to health! Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 61: Changing The Setpoint Ice Block Size
Touch the symbol [–] for the required ice block size (see table below). To accept the changes, touch the [Confirm] symbol. To reject the changes, touch the [Reject] symbol. Ice size parameter Meaning No ice No ice is to be formed. Setpoint ice block size: A small ice block is to be produced. Small ice block Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 62: Changing The Water Flow
This function enables you to change the automatic locking of controls (⇨ "Locked Controls", page 36). In addition, you can also deactivate the automatic locking. Touch the [Settings] symbol. Touch the [System lock] symbol. Select from the list the period of inactivity after which the HCU 40 is locked automatically. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 63: Changing The Brightness/Volume
If you wish to reject the changes, touch the [Reject] symbol. 4.4.6 Changing the Time, Date and Formats This function enables you to change the time, date and formats that the touchscreen displays. Touch the [Settings] symbol. Touch the [System] symbol. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 64 10 To accept the changes, touch the [Confirm] symbol. If you wish to reject the changes, touch the [Reject] symbol. ▶ The touchscreen shows the [Time/date] window. 11 To change the time and date format, touch the [Time/date format] symbol. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 65: Changing The Display Language
Touch the [Language] symbol. ▶ The touchscreen displays the following window: Select the desired language from the list. To accept the changes, touch the [Confirm] symbol. If you wish to reject the changes, touch the [Reject] symbol. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 66: System Information
▶ The touchscreen displays the following window: Left side: Patient water circuit Right side: Cardioplegia water circuit Ice level Meaning Water level too low/tank Filling/topping up water (⇨ "Filling/Topping Up Water", empty page 41) Top up water Filling/topping up water (⇨ "Filling/Topping Up Water", page 41) Water level low Filling/topping up water (⇨ "Filling/Topping Up Water", page 41) Water level normal Water level normal, no action necessary. Water level too high Drain water (⇨ "Causes of Faults and Measures to Take", page 78) Water level cannot be dis Device defective. Notify authorized service. played. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 67: Displaying The Ice Block Size
The displayed ice block size may deviate from the actual ice size. Open the tank cover and check the actual ice size visually. Touch the [Settings] symbol. Touch the [Tank] symbol. ▶ You are shown the following information. Parameter Meaning Setpoint ice block size To change the setpoint ice block size, touch the symbol (⇨ "Gradient Mode", page 49). Ice formation status patient Ice formation status (ice buildup) in patient water circuit water circuit tank Ice formation status cardio Ice formation status (ice buildup) in cardioplegia water cir plegia water circuit cuit tank Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 68: Displaying The Pressure Limits
4.5.4 Testing the Functioning of the Speaker and Warning Buzzer WARNING! Mortal danger to patient if acoustic signals do not sound! If no acoustic signals sound, stop using the device and contact the authorized service (⇨ "Authorized Service", page 131). Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 69: Testing Alarm Functions
Date of last water change and time remaining until next water change. An interval of 14 days is set at the factory. The factory-set intervals can be changed by the authorized service (⇨ "Inspection and Maintenance by Authorized Service Personnel", page 130). Touch the [Settings] symbol. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 70: Displaying The Power Supply Status
Measured frequency To close the window, touch the [Confirm] symbol. 4.5.8 Displaying System Information This function causes the touchscreen to display various data about the device. Touch the [Settings] symbol. Touch the [System] symbol. Touch the [System information] symbol. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 71: Putting Into Operation
The time required until the ice blocks are completely formed depends on the water temperature and ambient temperature. Set up the HCU 40 and connect the HCU 40 (⇨ "Setting up and Connecting the HCU 40", page 38). Connect the control unit (⇨ "Connecting a Control Unit", page 39). Instructions for Use | 1.0 | EN | 01...
Page 72: Check Before Every Application
Close the stopcocks (⇨ "Opening/Closing Stopcocks", page 40). Add water (⇨ "Filling/Topping Up Water", page 41). Switch the HCU 40 on (⇨ "Switching On the HCU 40, Self-Test", page 43). Create the necessary water circuits (⇨ "Creating a Water Circuit", page 52).
Page 73: During The Application
[Water level too high] (⇨ "Causes of Faults and Measures to Take", page 78). Close the tank cover. 4.6.4 On Completion of the Application Stop the pumps. Empty the tubes and the connected heat exchanger (⇨ "Emptying Water Circuits", page 58). Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 74: Emergency Procedures
With the "De-airing" function, ice-cold water is pumped from the tank into the tubes and the heat exchanger. The perfusion circuit in which the heat exchanger being de-aired is integrated must not be operated, as it could provoke a cardiac arrest if a patient is connected. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 75: Key User Functions
The small amount of air still remaining in the water circuit is removed via the air separator. NOTE The remaining air in an unfilled warming/cooling blanket cannot be removed via the air separator. 4.8 Key User Functions The "Service" screen is password-protected and may only be used by authorized personnel. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 76: Calling Up The "Service" Screen
Touch the desired character. To accept the input, touch the [Confirm] symbol. If you wish to reject the input, touch the [Reject] symbol. ▶ If you have correctly entered and confirmed the password, the touchscreen displays the following screen: Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 77 The touchscreen is calibrated with this function. In the “Service” screen, touch [Touchscreen calibration]. Always touch exactly in the center of the red cross. ▶ The HCU 40 checks the positions touched and calibrates the touchscreen accordingly. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 78: Troubleshooting
Fault Explanation/cause Recommended action by user Tank status [Water level too Water level too low. Fill/top up water (⇨ "Filling/ low/tank empty] and [Top up Water level in the main tank too Topping Up Water", page water] low when pump is running. 41), while observing the tank status (⇨ "Displaying the Tank Status", page 66). Tank status [Water level too Water level too high. Connect the drainage tube high] to the tank drainage coupling. Drain surplus water off, while observing the tank status (⇨ "Displaying the Tank Status", page 66). Disconnect the tube from the tank drain. Increase the setpoint ice block size (⇨ "Gradient Mode", page 49). Ice status [No ice] No ice. During the application (⇨ " During the Application", page 73). Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 79 Remove kink. No connection between CAN connection cable between Reconnect cable (⇨ " HCU 40 and CU. HCU 40 and CU not connected Connecting a Control Unit", during operation. page 39). CAN connection cable defec Replace CAN connection tive. cable with functioning cable (⇨ "Connecting a Control Unit", page 39). Connection to HCU 40 or CU Take HCU 40 or CU out of defective. service. Use replacement device. Touchscreen of the CU is blank The CU must be reset. Disconnect and reconnect or does not react CAN connection cable between HCU 40 and CU. Check the set values. HCU 40 and CU not functioning Internal power supply defec Take HCU 40 and CU out tive / Defective power plug or of service. power cord. Use replacement device. External power supply defec Check external power tive. supply. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 80 Deairing cannot be performed. Overly large ice blocks impair Reduce setpoint ice block water circulation. size. The stopcock is not fully open. Open the stopcock of the relevant circuit (⇨ " Opening/Closing Stopcocks", page 40). Water tube kinked. Remove kink. If you cannot confirm a fault, switch the HCU 40 off and back on again. If the fault occurs repeatedly, contact Maquet (⇨ "Authorized Service", page 131) service. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 81: Messages
Alarms", page 82) and (⇨ "Technical Alarms", page 82). ▶ The HCU 40 displays current alarms, according to priority, on a colored background: Red: high-priority alarm, Yellow: low or medium-priority alarm. To close the alarm list, touch the [Confirm] button. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 82: Physiological Alarms
If the "Water pressure too high" alarm is emitted, check whether the outlet valve is closed or if a tube is kinked. WARNING! Operating the pump with an empty tank can damage the device! If the tank is empty, the pump can run dry and be damaged. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 83: High Priority
Outlet temperature Check setpoint temper ture too high above warning limit ature and reduce if nec essary. Message disap pears automatically when temperature drops below warning limit. Pat.: Heater tempera Patient temperature not Temperature turned off ture too high! regulated until device because temperature at cools down. outlet too high. Operation in too hot en Reduce temperature at vironment outlet to below 39.5°C: allow device to cool Temperature in device down. Place device in too high (temperature cooler environment. buildup in standby) Supply cold air. Use re placement device. Temperature sensor Check plausibility of the defective temperature display on the CU. Notify the au thorized service in case of defects. Use replace ment device. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 84: Medium Priority
Gradient mode not External temperature Check connection to mode possible... available. sensor defective or external temperature connection faulty. sensor. Reconnect if necessary. Cplg.: Water pressure No circulation and thus Outlet valve closed. Open outlet valve. too high! no temperature regula Tube kinked. Remove kink. tion possible. Cplg.: Tank tempera If the water tempera Temperature in the Activate ice formation. ture too high! ture exceeds 42°C: tank too high or tem Replace water in tank The safety shutdown is perature sensor defec with colder water. If the triggered. No circulation tive error occurs again: No until the water has tify authorized service. cooled down. Use replacement de vice. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 85 Pat.: Water flow too No circulation and thus Outlet valve closed. Open outlet valve. low! no temperature regula Tube kinked. Remove kink. tion possible. Blanket operated with Connect pressure re out pressure reducer. ducer. Pat.: No gradient mode Gradient mode not External temperature Check connection to possible available. sensor defective or external temperature connection faulty. sensor. Reconnect if necessary. Pat.: Water pressure No circulation and thus Outlet valve closed. Open outlet valve. too high! no temperature regula Tube kinked. Remove kink. tion possible. Blanket operated with Connect pressure re out pressure reducer. ducer. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 86 Voltage supply too low. Compare required de tions vice voltage with mains voltage. Ensure suffi cient and stable power supply. In case of fre quent mains voltage disruptions, notify au thorized service and have the device ad justed to a lower input voltage. Fan defective! Com Ice formation disrupted. Fan 1 or 2 defective or Clean the fan or if nec pressor off! blocked. essary have it replaced by authorized service. Selftest failed HCU 40 functions af Broken cable, controller Switch the HCU 40 off fected defective, incorrect and back on again. mains voltage or mains Change mains input frequency, water level voltage if possible. No too high/low, heater de tify authorized service. fective or sensors de Use replacement de fective. vice. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 87: Low Priority
Control unit defective. If the error occurs again: Notify authorized service. Cplg.: Ext. temp. Gradient mode not External temperature Reconnect sensor or sensor disconnected! available. sensor disconnected. confirm disconnection, if necessary. Cplg.: Ext. temp. out of Gradient mode not External temperature Check the actual tem range available. sensor defective! perature. Change ex ternal temperature sensor. Cplg.: Tank temp. Displayed tank temper Temperature sensor Notify authorized ser sensor defective! / ature is incorrect. There defective. vice. Use replacement Visually check ice. may not be any cooling device. of the patient Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 88 Water level sensor de Displayed water level is Level sensors defec Notify authorized ser fective! Check water incorrect tive. vice. Use replacement level visually device. Check water level visually. Top up water if necessary. Top up water in tank If water level falls fur Too little water in the Fill the water tank. ther: No circulation with tank. empty tank, and there Level sensors defec If the error occurs fore no temperature tive. again: Notify authorized regulation possible. service. Use replace ment device. Pat.: Tank temperature Tank may freeze. Sensor faulty. Reduce setpoint ice too low. Danger of block size. Check ice frozen tank! Check ice thickness visually. thickness visually. If necessary, reduce ice formation. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 89 Pat.: Ext. temp. out of Gradient mode not External temperature Check the actual tem range! available. sensor defective! perature. Change ex ternal temperature sensor. Control unit defective. If the error occurs again: Notify authorized service. Pat.: Tank temp. Displayed tank temper Tank temperature Notify authorized ser sensor defective! ature is incorrect. There sensor defective! vice. Use replacement Check ice visually. may not be any cooling device. of the patient. Mains voltage too high. Device can overheat Supply voltage too high Check supply voltage and be damaged. or voltage measure at HCU 40 (CU). In ment incorrect. case of doubt, contact service. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 90: Messages
| 90 | 6 Messages | HCU 40 | 6.5 Messages Text of message Meaning System locked! Locked controls (⇨ "Locked Controls", page 36) Next date for inspection in <x> days! Inspection and maintenance by authorized ser vice personnel (⇨ "Inspection and Maintenance by Authorized Service Personnel", page 130) Inspection interval has expired! Inspection and maintenance by authorized ser vice personnel (⇨ "Inspection and Maintenance by Authorized Service Personnel", page 130) Cleaning interval has expired! Perform cleaning. Inspection and maintenance by authorized ser vice personnel (⇨ "Inspection and Maintenance by Authorized Service Personnel", page 130) Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 91: Cleaning, Descaling And Disinfection
Disinfect the surfaces after each use. You can use the following disinfectants: Tosylchloramide sodium (Chloramine-T) Alcohol (ethanol, isopropyl, 70% by vol.) Bacillol (Bode Chemie) Buraton 10F (Schülke & Mayr) Buraton rapid (Schülke & Mayr) Mikrobac forte (Bode Chemie) Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 92: Descaling And Disinfection Of The Water Circuits
190 x 120 x 40 mm (L x W x H) in size If stopcocks for the pumps of the patient and cardioplegia water circuits are mounted underneath the HCU 40: Flat tray (chemical-resistant) which is placed below the HCU 40, approx. 450 x 300 x 50 mm (L x W x H) in size Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 93 (e.g., chemical-resistant nitrile or butyl rubber gloves, dust mask for P2 respiratory protection, protective goggles and laboratory coat). The descaling/disinfection agent may only be used pre- and post-operatively, and never during the actual intervention. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 94 The HCU 40 supports you with a wizard to guide you step by step. The intervals can be found in the overview (⇨ "Maintenance", page 128). Routine disinfection cannot replace hygiene monitoring. It may be necessary to shorten the interval. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 95: Performing Descaling
(example: shut-off valve not open during pumping) A warning to this effect is shown. You can continue the cleaning routine by pressing the [Next] symbol. Touch the [Settings] symbol. Touch the [Cleaning/emptying] symbol. Touch the [Cleaning] symbol. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 96 If the tubes for the patient and cardioplegia water circuits were connected to the cleaning connectors on the HCU 40 during melting, remove Patient water circuit 1: these cleaning connectors. Stopcock Water outlet 1/2" Water inlet 1/2" (backflow) Patient water circuit 2: Stopcock Water outlet 1/2" Water inlet 1/2" (backflow) Cardioplegia water circuit: Stopcock Water outlet 3/8" Water inlet 3/8" (backflow) Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 97 11 Disconnect the cleaning connectors and disinfect the Hansen couplings and the cleaning connectors. 12 Perform surface cleaning and disinfect the device (⇨ "Surface Cleaning and Disinfecting the Device after Each Use", page 91). 13 Connect the cleaning connectors. 14 Touch the [Next] symbol. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 98 Touch the [Next] symbol. Fill the HCU 40 up to the white mark in the tank with sterile filtered water (1 cm above the cooling plates). ▶ The water level is shown on the 4th marking Touch the [Next] symbol. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 99 17 Close the stopcocks of the patient and cardioplegia water circuits. 18 Disconnect the cleaning connectors. 19 Place the open ends of the tubes (without touching any contaminated surfaces) in an outflow and open the stopcocks of the patient and cardioplegia water circuits. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 100 Connect the drainage tube to the tank drainage coupling and collect the remaining water (2 to 3 liters) in a suitable container (e.g., a flat stainless steel tray). NOTE Use a suitable outflow to dispose of the disinfection/descaling agent solutions. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 101 Disconnect the cleaning connectors. Place the open ends of the tubes (without touching any contaminated surfaces) in an outflow and open the stopcocks of the patient and cardioplegia water circuits. Touch the [Next] symbol. ▶ The HCU 40 pumps the water out. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 102 The HCU 40 de-airs the cardioplegia and patient water circuits. Disconnect the cleaning connectors. Place the open ends of the tubes (without touching any contaminated surfaces) in an outflow and open the stopcocks of the patient and cardioplegia water circuits. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 103 Fill the HCU 40 up to the white mark in the tank with sterile filtered water (1 cm above the cooling plates). Touch the [Next] symbol. ▶ The HCU 40 de-airs the cardioplegia and patient water circuits. Disconnect the cleaning connectors. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 104 11 Fill the HCU 40 up to the white mark in the tank with sterile filtered water (1 cm above the cooling plates). 12 To exit the wizard after the last step, touch the [Confirm] symbol. To cancel the wizard instead, touch the [Reject] symbol. ▶ Descaling completed. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 105: Performing Weekly Routine Disinfection
A warning to this effect is shown. You can continue the cleaning routine by pressing the [Next] symbol. Touch the [Settings] symbol. Touch the [Cleaning/emptying] symbol. Touch the [Cleaning] symbol. ▶ You will see a wizard that will guide you through disinfection. Touch the [Next] symbol. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 106 Place the open ends of the tubes (without touching any contaminated surfaces) in an outflow and open the stopcocks of the patient and cardioplegia water circuits. Touch the [Next] symbol to start pumping. ▶ The HCU 40 pumps the water out. Wait until the HCU 40 is empty. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 107 Disinfecting the Device after Each Use", page 91). 13 Connect the cleaning connectors. 14 Touch the [Next] symbol. Routine disinfection Fill the HCU 40 with sterile filtered water up to the second mark on the water level indicator. Touch the [Next] symbol. Put on protective clothing. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 108 Fill the HCU 40 up to the white mark in the tank with sterile filtered water (1 cm above the cooling plates). ▶ The water level is shown on the 4th marking Touch the [Next] symbol. Open the stopcocks of the patient and cardioplegia water circuits. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 109 19 Place the open ends of the tubes (without touching any contaminated surfaces) in an outflow and open the stopcocks of the patient and cardioplegia water circuits. NOTE Use a suitable outflow to dispose of the disinfection/descaling agent solutions. 20 Touch the [Next] symbol. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 110 NOTE Use a suitable outflow to dispose of the disinfection/descaling agent solutions. 24 Touch the [Next] symbol. 25 Close the water pump stopcocks, reattach the yellow caps and disconnect the drainage tube. Disconnect the drainage tube. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 111 HCU 40: Connect the drainage tube to the tank drainage coupling and collect the remaining water (2 to 3 liters) in a suitable container (e.g., a flat stainless steel tray). Touch the [Next] symbol. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 112 Disconnect the cleaning connectors. Place the open ends of the tubes (without touching any contaminated surfaces) in an outflow and open the stopcocks of the patient and cardioplegia water circuits. Touch the [Next] symbol. ▶ The HCU 40 pumps the water out. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 113 The HCU 40 de-airs the cardioplegia and patient water circuits. Disconnect the cleaning connectors. Place the open ends of the tubes (without touching any contaminated surfaces) in an outflow and open the stopcocks of the patient and cardioplegia water circuits. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 114 11 Fill the HCU 40 up to the white mark in the tank with sterile filtered water (1 cm above the cooling plates). 12 To exit the wizard after the last step, touch the [Confirm] symbol. To cancel the wizard instead, touch the [Reject] symbol. ▶ Weekly routine disinfection completed. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 115: Performing Highly Effective Disinfection And Biofilm Removal
A warning to this effect is shown. You can continue the cleaning routine by pressing the [Next] symbol. Touch the [Settings] symbol. Touch the [Cleaning/emptying] symbol. Touch the [Cleaning] symbol. ▶ You will see a wizard that will guide you through disinfection. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 116 Place the open ends of the tubes (without touching any contaminated surfaces) in an outflow and open the stopcocks of the patient and cardioplegia water circuits. Touch the [Next] symbol to start pumping. ▶ The HCU 40 pumps the water out. Wait until the HCU 40 is empty. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 117 13 Connect the cleaning connectors. 14 Touch the [Next] symbol. Highly effective disinfection and biofilm removal Fill the HCU 40 with sterile filtered water up to the second mark on the water level indicator. Touch the [Next] symbol. Put on protective clothing. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 118 Touch the [Next] symbol. Fill the HCU 40 up to the white mark in the tank with sterile filtered water (1 cm above the cooling plates). ▶ The water level is shown on the 4th marking Touch the [Next] symbol. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 119 18 Leave the Chloramine-T to work for 24 hours in the water system 19 Disconnect the cleaning connectors. 20 Place the open ends of the tubes (without touching any contaminated surfaces) in an outflow and open the stopcocks of the patient and cardioplegia water circuits. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 120 Connect the drainage tube to the tank drainage coupling and collect the remaining water (2 to 3 liters) in a suitable container (e.g., a flat stainless steel tray). NOTE Use a suitable outflow to dispose of the disinfection/descaling agent solutions. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 121 Disconnect the cleaning connectors. Place the open ends of the tubes (without touching any contaminated surfaces) in an outflow and open the stopcocks of the patient and cardioplegia water circuits. Touch the [Next] symbol. ▶ The HCU 40 pumps the water out. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 122 The HCU 40 de-airs the cardioplegia and patient water circuits. Disconnect the cleaning connectors. Place the open ends of the tubes (without touching any contaminated surfaces) in an outflow and open the stopcocks of the patient and cardioplegia water circuits. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 123 Fill the HCU 40 up to the white mark in the tank with sterile filtered water (1 cm above the cooling plates). Touch the [Next] symbol. ▶ The HCU 40 de-airs the cardioplegia and patient water circuits. Disconnect the cleaning connectors. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 124 11 Fill the HCU 40 up to the white mark in the tank with sterile filtered water (1 cm above the cooling plates). 12 To exit the wizard after the last step, touch the [Confirm] symbol. To cancel the wizard instead, touch the [Reject] symbol. ▶ Highly effective disinfection and biofilm removal completed. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 125: Emptying The Tank
▶ The HCU 40 melts the ice block and adjusts the temperature of the tank water to 20°C. Duration: 30 up to a maximum of 75 minutes (depending on the amount of ice present and the power supply). Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 126 Stopcock Water outlet 3/8" Water inlet 3/8" (backflow) Place the open ends of the tubes in an outflow and open the stopcocks of the patient and cardioplegia water circuits. Touch the [Next] symbol to start pumping. 10 Wait until the HCU 40 is empty. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 127: Cleaning The Air Filter
To cancel the wizard instead, touch the [Reject] symbol. 7.3 Cleaning the Air Filter A soiled air filter can impair the cooling capacity. Clean the air filter from the outside with a vacuum cleaner every 4 weeks. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 128: Maintenance
The water level in the tank is sufficient (setpoint water level: level marking in the cardioplegia tank, approx. 1 cm above the evaporizer plates). The size of the ice block is sufficient. The interior walls of the tank must not be touched by the ice in order to allow sufficient flow. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 129: Perform Diagnosis
Once the circuit has been de-aired, a green check mark appears next to [De-airing] symbol. 10 Touch the [Settings] symbol. 11 Touch the [Diagnosis] symbol. 12 Follow the wizard's instructions. 13 To confirm that you have followed the instructions, touch the [Continue] symbol. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 130: Inspection And Maintenance By Authorized Service Personnel
8.2 Inspection and Maintenance by Authorized Service Personnel The regular inspection and maintenance by authorized service personnel includes a safety check and extensive maintenance measures. WARNING! The inspection may only be carried out by a service technician authorized by Maquet. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 131: Inspection
Repairing restores the proper functioning of the device and ensures it is free from damage. It is necessary if, for example, a fault has occurred in the device. WARNING! Repairs may only be carried out by a service technician authorized by Maquet. 8.3.1 Send Device to Authorized Service Point Switch off the device.
Page 132: Initial Installation
WARNING! Initial installation may only be carried out by a service technician authorized by Maquet (⇨ "Send Device to Authorized Service Point", page 131). NOTE Permissible maximum pressure As part of the initial installation, the permissible maximum pressure is adapted to suit the heat exchangers employed.
Page 133: Accessories
Tube and coupling sets Tubing set for oxygenator/heat exchanger with 2 x 6 m 1/2" Hansen coupling 2 x 10 m 2 x 15 m Tubing set for cardioplegia heat exchanger with 2 x 6 m 3/8" Hansen coupling 2 x 10 m 2 x 15 m Blanket connection kit (incl. pressure reducer for 6 m (3 + 3 m) warming/cooling blankets) 9 m (6 + 3 m) Pressure reducer for blanket connection kit For warming/cooling blankets. Contained in the blanket connection kit for the HCU 40. Warming/cooling blanket Adult (Gaymar; CBA 20730) Pediatric (Gaymar; CBA 20731) Bypass tubing set (for diagnosis) for patient water circuit (with 1/2" Hansen coupling, length 1 m) for cardioplegia water circuit (with 3/8" Hansen coupling, length 1 m) Drainage tube Hansen coupling kit for patient water circuit 1/2" straight 1/2" angled Hansen coupling kit for cardioplegia water circuit 3/8" straight 3/8" angled Sensors External temperature sensors TPOD L1.8 (dia. 0.125" x L1.77") TPOD L1.8 Pediatric (dia. 0.095" x L1.38") Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 134 | 134 | 10 Accessories | HCU 40 | Data exchange USB 2.0 cable type A – type B Length 3 m Length 5 m CAN connection cable for connecting HCU 40 to Length 7 m control unit (CU) Length 10 m Length 15 m Cleaning Disinfectant, powder, 500 g, (active ingredient: tosylchloramide sodium (ChloramineT)) Mixing bottle for diluting the disinfectant Cleaning connector (double Hansen coupling) Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 135: Technical Data
| HCU 40 | 11 Technical Data | 135 | 11 Technical Data 11.1 HCU 40 Device Classification in accordance with Council Direc tive 93/42/EEC concerning medical devices, Ap pendix IX Degree of protection in accordance with IP 22 (Protection against ingress of solid foreign IEC 60529 objects larger than 12.5 mm and dripping water when tilted up to 15°) Classification in accordance with IEC 606011 HCU 40 Type B applied part Ext. temperature sensors – Defibrillator protected type CF applied part Oxygenator heat exchanger – type B applied part Cardioplegia heat exchanger – type B applied part Warming/cooling blanket – type BF applied part Dimensions (HxWxD) 1133 x 508 x 703 mm (880 x 508 x 688 mm without CU and holder) Weight (incl. CU and holder, excl. tubes) 154 kg Volume (at 3 m distance) 40.4 dB (at 50 Hz), 44.3 dB (at 60 Hz) (patient and cardioplegia pump turned on, compressor turned off) 44.8 dB (at 50 Hz), 46.8 dB (at 60 Hz); (patient and cardioplegia pump turned on, compressor turned on) Speaker for acoustic alarms Volume depends on the priority of the alarm (⇨ "...
Page 136: Control Unit Cu
Frequency 50/60 Hz Line fuse 25 A (110 … 240 V) Supply line (Building installation requirements) Exclusively used for HCU 40 Designed for current rating > 16 A (country specific) Protected by type C circuitbreaker type C and ground fault circuit interrupter Water supply Water hardness ≤ 2.5 mmol/l CaCO3 (14 °dH) Do not use deionized water! 11.2 Control Unit CU Dimensions (H x W x D) 174 x 210 x 70 mm Weight (incl. holder) 1.3 kg Touchscreen LCD, 115.2 x 86.4 mm, 640 x 480 pixels 11.3 Permissible Heat Exchangers 11.3.1 Oxygenator and Cardioplegia Heat Exchangers Permissible water flow Cardioplegia heat exchanger: at least 2 l/min Oxygenator heat exchanger: at least 3 l/min Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 137: Blanket Connection Kit (Incl. Pressure Reducer)
11.3.2 Blanket Connection Kit (incl. Pressure Reducer) Nominal pressure of pressure reducer Max. 1.2 bar 11.4 Components Supplied HCU 40 Power cable Instructions for Use Control unit CU (incl. holder and pole for securing) CAN connection cable for HCU 40 – CU connection, length 1 m Tubing set for oxygenator/heat exchanger with 1/2" Hansen coupling (straight or angled), 2 x 6 m Tubing set for cardioplegia heat exchanger with 3/8" Hansen coupling (straight or angled), 2 x 6 m 2 cleaning connectors (double Hansen connectors) Drainage tube Bypass tubing set for patient water circuit with 1/2" Hansen coupling, length 1 m Bypass tubing set for cardioplegia water circuit with 3/8" Hansen coupling, length 1 m Disinfectant, powder, 500 g (active ingredient: Tosylchloramide sodium (Chloramine T)) Mixing bottle for diluting the disinfectant 11.5 Ambient Conditions Operation Storage and transport Temperature +10 … +30ºC 20 … +60ºC Relative humidity (noncon 0 … 85% 10 … 96% densing) Air pressure (absolute) 800 … 1060 hPa 700 … 1060 hPa Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 138: Measured Data And Displayed Data
The measuring range depends on the disposable. 11.7 Possible Settings and Factory Settings 11.7.1 Temperatures and Water Flows Parameter Possible values Resolution Factory setting Setpoint temperature: Cardioplegia water 1 … 40.5°C 0.1°C 37°C circuit Patient water 1 … 40.5°C 0.1°C 37°C circuit Gradient: Cardioplegia water Off, 1.0 ... 15.0°C 0.1°C circuit Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 139: Accuracy Of The Temperature Control
11.7.2 Accuracy of the Temperature Control Parameter Accuracy Warming (20°C to 40°C) ±0.5°C Cooling (40°C to 20°C) ±1.5°C 11.7.3 Hotkeys Option Possible settings Factory setting Pump control Cardioplegia water circuit On, off Patient water circuit On, off Acoustic alarm On, temporarily off Compressor control: Compressor On, off – (automatic control) Size of ice block: Cardioplegia water circuit 1 ... 3 (in increments of 1) Patient water circuit 1 ... 3 (in increments of 1) Automatic blocking deactivated, 30 s, 1 min, 2 min, deactivated 5 min, 10 min Brightness/volume: Brightness 1 ... 10 (in increments of 1) Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 140: Availability Of Physiological Alarms For External Devices
41.0°C for 10 seconds. When this limit is exceeded, the heater switches off immediately, and a high-priority alarm is emitted optically and acoustically. A water temperature of 42.0 ± 0.5°C can occur in a type 1 error situation for a maximum of 60 seconds. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 141: Solution Concentration With Different Tube Lengths
(in liters) (in liters) circuit 82 ml/m 132 ml/m 132 ml/m Tubing HCU 40 2 x 15 m 2.45 3.95 3.95 10.35 38.4 770 g 2 x 10 m 1.64 2.64 2.64 6.92 34.9 700 g 2 x 6 m 0.98 1.58 1.58 4.14 32.1 640 g 2 x 1 m 0.16 0.26 0.26 0.69 28.0 560 g Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 142: Per Cent Chloramine-T Concentration For Highly Effective Disinfection And Biofilm Removal Of Various Tube Lengths
82 ml/m 132 ml/m 132 ml/m Tubing HCU 40 5 % 2 x 15 m 2.45 3.95 3.95 10.35 38.4 2 x 960 g 2 x 10 m 1.64 2.64 2.64 6.92 34.9 2 x 875 g 2 x 6 m 0.98 1.58 1.58 4.14 32.1 2 x 805 g 2 x 1 m 0.16 0.26 0.26 0.69 28.0 2 x 700 g Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 143: Applied Standards
Guidance and manufacturer's declaration – Electromagnetic immunity The HCU 40 is intended for operation in the electromagnetic environment detailed below. The customer or the user of the device should ensure that it is used in such an environment. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 144 (> 95% dip) (> 95% dip) Magnetic field 3 A/m 3 A/m The strength of powerfrequency mag with a power fre netic fields should correspond to that quency of a typical commercial or hospital en (50/60 Hz) as vironment. IEC 6100048 Note: U is the AC supply voltage prior to application of the test level. Portable and mobile RF communica tions equipment should be used no closer to any part of the device, includ ing cables, than the recommended separation distance calculated from the equation applicable to the fre quency of the transmitter. Recommended separation distance: Conducted RF 3 V 150 kHz to 10 V d = 0.35 √P IEC 6100046 80 MHz Radiated RF 3↓V/m 80 MHz to 10 V/m d = 0.35 √P 80 MHz to 800 MHz IEC 6100043 2.5 GHz d = 0.7 √P 800 MHz to 2.5 GHz Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 145 RF disturbances are controlled. The customer or the user of the device can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device, as recommended below, according to the maximum output power of the communications equipment. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 146 Separation distance according to frequency of transmitter [m] mum output 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz power of transmitter d = 0.35 √P d = 0.35 √P d = 0.7 √P 0.01 0.035 0.035 0.07 0.11 0.11 0.22 0.35 0.35 1.11 1.11 2.21 For transmitters rated at an output power not listed above, the distance can be estimated using the equation applicable to the frequency of the transmitter, where P is the output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Instructions for Use | 1.0 | EN | 01 Copyright Maquet Cardiopulmonary GmbH...
Page 148 We operate under the three Phone: +49 7222 932-0 brands of ArjoHuntleigh, GETINGE and MAQUET. ArjoHuntleigh focuses on patient mobility and wound management solutions. Fax: +49 7222 932-1888 GETINGE provides solutions for infection control within healthcare info.cp@maquet.com...

Maquet HCU 40 Instructions For Use Manual

1 General

2 Safety

3 System Description

4 Operation

5 Troubleshooting

6 Messages

7 Cleaning, Descaling and Disinfection

8 Maintenance

9 Initial Installation

10 Accessories

11 Technical Data

12 Applied Standards

Quick Links

Need help?

Questions and answers

Related Manuals for Maquet HCU 40

Summary of Contents for Maquet HCU 40

Table of Contents